Irrigation of a surgical or operative site accomplishes three goals. First, flushing the site with fluid cleans the area of blood and tissue providing a surgeon with an improved view. Secondly, the fluid functions as a medium for removal of blood and debris during aspiration of the operative site. Thirdly, pressurized irrigant is used to gently separate anatomical structures for accessing adjacent structures. High pressure irrigant is desired for use in laser surgery, however, well known systems cannot provide sufficient pressure for that use.
Irrigation delivery systems typically include measurement and control instruments to adjust flow rates, a reservoir for the sterile irrigation fluid, a pump or other flow producing means, a flexible sterile conduit, and an operative instrument for discharging fluid to an operative site.
Well known irrigation systems include gravity systems, pressurized gas systems, various mechanical pump designs, and pressure vessel compression systems. The gravity systems usually suspend the irrigation fluid at an elevated height to produce fluid flow. A problem associated with gravity systems is that, typically, these systems cannot achieve high flow rates.
Pressurized gas systems pump gas into a sterile fluid container and force the fluid out of the container, through a conduit and into an operative instrument for delivery to the operative site. A problem with gas systems is that the gas contacts the sterile fluid and may introduce contaminants into the fluid. Another problem with these systems is cross-flow contamination. Cross-flow contamination occurs when contaminated fluid at the operative site backflows into the sterile conduit.
Mechanical pumps include complex pneumatic, systolic, and peristaltic pumps as well as disposable sterile pumps. Pumps are generally undesirable because they are not self contained, operate at high noise levels, and contaminate the sterile irrigation fluid.
A pressure vessel system utilizes a rigid housing for holding a flexible fluid bag. Flow is achieved pressurizing the area within the housing with either gas or fluid such that the bag is compressed. Problems associated with these systems are a small irrigant capacity and contamination at the interfaces between the housing and the tubing connected to the housing. In addition, this type of system is often undesirable because it utilizes a hospital's gas supply line which limits the system's mobility and makes the gas supply line unavailable for other uses. It is desirable to have irrigation fluid preheated to prevent patient hypothermia, however, there are frequently pre-surgery delays during which the fluid cools. Consequently, a system capable of maintaining fluid at its preheated temperature is desired. One system that has attempted to solve this problem is a heated water bath where the bags of irrigant are immersed in the bath and fluid is pumped from the bag up through the control system. However, disadvantages associated with this system are that the system is not self contained, is cumbersome, and is inconvenient. Another system provides a sleeve having a heating element that slides over a portion of the tubing so that fluid is heated as it travels through that portion of the tubing. Problems associated with this system are that the preheated temperature is not maintained and the sleeve is inconvenient and time consuming to use.
Another disadvantage associated with existing irrigation systems is that changing an empty reservoir of fluid is time consuming and inconvenient so that it often interrupts surgery.
It is the object of this invention to provide a simple, self-contained, mobile irrigation system which is capable of providing highly pressurized irrigant; the elimination of irrigant contamination; a large volume of irrigant; its own gas supply through a self-contained method of pressurization; warm irrigant to the operative site; irrigant at a pressure which is sufficient for use in laser surgery; convenient and quick changing of irrigation bags; and quiet operation at less than 40 dBA.